Research and Analysis on the Implementation of Drug Vigilance among Drug Marketing Permit Holders in Jining and Heze Cities
OBJECTIVE To investigate the current situation,problems,and suggestions of drug surveillance ac-tivities implemented by drug marketing license holders in Shandong Province.METHODS A questionnaire survey was conducted on relevant institutions and personnel of drug marketing license holders in Jining and Heze cities,and the implementation of drug vigilance activities by holders was summarized and analyzed from eleven aspects(11 ma-jor items and 40 minor items).RESULTS A total of 50 survey questionnaires were distributed to drug marketing li-cense holders in Jining and Heze cities,with 46 questionnaires collected and a response rate of 92％.The holder has problems such as incomplete drug vigilance system,blocked channels for collecting safety information,need to im-prove the ability to manage and utilize reports,and weak risk assessment and control capabilities.CONCLUSION Holders need to further strengthen their sense of main responsibility,establish a reasonable organizational structure,e-quip necessary resources and equipment,facilitate information collection channels,improve risk prevention and con-trol levels,and continuously enhance their ability and level of drug vigilance.
Drug vigilanceImplementation statusResearchListing permit holder
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